Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma
NCT ID: NCT01570049
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2010-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine
Dose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles.
Bendamustine
for injection
Interventions
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Bendamustine
for injection
Eligibility Criteria
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Inclusion Criteria
* B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL
* Rituximab refractory or relapsed lymphoma patients
* At least 1 measurable tumor with shortest diameter being of \> 1.0cm and longest diameter being of \> 1.5cm
* ECOG PS ≤ 2
* Anticipated Survival is more than 3 months
* Hematopoietic function is normal during 14 days before enrollment (unless those abnormities related to lymphoma aggression), including: hemoglobin (Hb) ≥ 8.0g/dl (5.0mmol/L); absolute neutrophil count (ANC) ≥ 1.5X109/L; Platelet count (PLT) ≥ 80X109/L. Acceptable range for abnormities related to lymphoma aggression: Platelet count (PLT) ≥ 50X109/L; White blood cell count (WBC) ≥ 3.5X109/L; Absolute neutrophil count (ANC) ≥ 1.0X109/L
* Female subjects should not be pregnant and breast-feed, should have contraceptive method during the clinical trial and 12 months thereafter.
* Subject (or his/her legal representative) agrees to participate the trial and sign the informed consent form
Exclusion Criteria
* Transferred to high grade malignant lymphoma (from low grade follicular lymphoma)
* 3b grade follicular lymphoma
* With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis )
* With other anticancer treatment during the last 4 weeks
* Regularly administrated corticosteroid during the last 4 weeks, unless the dose is less or equivalent to 20mg/d prednisone
* Had tumors or have other tumors, not including non-melanoma skin cancers and cervical carcinoma in situ be treated properly
* Underwent surgical operation within 28 days before enrollment (exclude lymph node biopsy)
* Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal value
* Hepatic insufficiency: serum total bilirubin is \> 1.5 times of upper limit of normal value; AST, ALT is \> 2.5 times of upper limit of normal value
* Known HIV infection or HBV, HCV related active infections; HBsAg is positive; HBcAb is positive and virus copy number is \> 1000
* For patients with other severe medical diseases interfering with their participations of this study(e.g., infections and diabetes not controlled well, gastric ulcer, other lung diseases, active autoimmune diseases), the suitability of participation is judged by investigators
* Patients participated in other clinical studies and got medical treatments within 30 days prior to enrollment of this trial
* Other medical and psychological conditions that influence the patients participation or signing of informed consent form
18 Years
75 Years
ALL
No
Sponsors
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Shandong Lanjin Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Huaqing Wang, master
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Huaqing Wang, Master
Role: CONTACT
Phone: +86-022-2334-0123
Facility Contacts
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Huaqing Wang, Master
Role: primary
Huaqing Wang, Master
Role: primary
Jian J Yu, Master
Role: backup
Other Identifiers
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RGB-NHL
Identifier Type: -
Identifier Source: org_study_id